Safety and blood levels of CSL730 in Japanese volunteers; v1
Research type
Research Study
Full title
A phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous CSL730 in healthy Caucasian and Japanese subjects. (17-009)
IRAS ID
240493
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
CSL Behring GmbH
Eudract number
2017-003478-15
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (CSL730) is an experimental new medicine that may eventually be used for the treatment of some diseases that involve inflammation. Normally the immune system helps protect the body from harmful substances, including infections. In patients with autoimmune diseases, the immune system can’t tell the difference between healthy body tissue and harmful substances. This results in inflammation and tissue damage. The study medicine contains parts of a protein called a ‘monoclonal antibody’, which is made specifically for use in humans (antibodies are proteins made by the immune system in response to a foreign substance). It works by blocking a substance called Fc gamma receptors (FcγRs), which is found on the surface of certain cells within the immune system. We hope that, by blocking FcγRs, the study medicine will reduce the inflammation and tissue damage.
If this and future studies are successful, the study medicine may be useful for treating patients in many countries, including in Japan. First, we need to test it in healthy Japanese people, so we can compare the results across other ethnic groups.We’ll give up to 24 healthy Japanese participants, aged 20–55 years, a single dose of study medicine, by slow injection into a vein, to find out its side effects and blood levels. We'll also investigate whether the body reacts to CSL730; in particular, whether the body makes antibodies against it.
Participants will take up to 11 weeks to finish the study. They’ll make up to 7 outpatient visits, and stay on the ward for 4 nights.
A pharmaceutical company (CSL Behring GmbH, Germany ) is funding the study.
The study will take place at 1 centre in London in the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/0044
Date of REC Opinion
10 Apr 2018
REC opinion
Further Information Favourable Opinion